JP4755468B2 - 結合組織の除去のための装置および方法 - Google Patents
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Description
本発明は、一般に医療用デバイス、キット、および方法に関する。より具体的には、本発明は、組織表面の下にある組織領域から組織を除去するための装置および方法に関する。
固形組織において組織容積の無線周波数の電気外科的切除のためのループ電極が、Lorentzenら(1996)Min.Invas.Ther.&Allied Tecnol.5:511−516に記載される。
組織表面の下から固形組織を除去するための装置および方法が提供される。これらの方法は、エネルギー伝達要素を組織表面の下の標的部位に配置する工程、およびその組織を気化し得るようにこの要素にエネルギー供給する工程に依存する。要素(18)は、次いで、所望の組織に除去構造(例えば、球形、卵形または円筒形)を提供する様式で、移動される。通常、シャフト(12)は、移動され、典型的には、回転または往復運動され、そしてエネルギー伝達要素(18)は、典型的に、剛性要素を回転させるかまたは可撓性要素を曲げることによって、シャフト(12)に対して移動される。
1.組織表面の下の一定容量の固形組織を除去するための方法であって、該方法は、以下:
エネルギー伝達要素を、該組織表面の下の該固形組織中の標的部位に配置する工程;
該エネルギー伝達要素にエネルギー供給する工程;および
該エネルギー供給された要素を、連続組織層を通して移動させる工程であって、ここで、該要素は、該連続層中の組織を気化するのに十分なエネルギーでエネルギー供給されて、所望の除去容量を生成する、工程、を包含する、方法。
2.組織表面の下の一定容量の固形組織を除去するための方法であって、該方法は、以下:
シャフトおよび再配置可能なエネルギー伝達要素を有する機器を提供する工程;
該要素を、該組織表面を通して該固形組織中の標的部位まで前進させる工程であって、ここで、該要素は低プロフィール構成であり、そして該シャフトの近位端は該固形組織の外側に残存する工程;
該シャフトを該組織表面に対して移動させる工程;
該要素を該シャフトに対して再配置する工程;および
該要素にエネルギー供給する工程、を包含し、
ここで、該シャフトの組合せ移動および該要素の再配置により、該要素が連続組織層を通過し、そしてここで、該要素は、該連続層中の組織を気化するのに十分なエネルギーでエネルギー供給されて、所望の除去容量を生成する、方法。
3.前記固形組織が、乳房、肝臓、腎臓、前立腺、子宮および肺からなる群から選択される器官を含む、項目1または2に記載の方法。
4.前記固形組織を画像化し、該画像に基づいて、前記エネルギー伝達要素を配置する工程をさらに包含する、項目1または2に記載の方法。
5.画像法が、蛍光透視画像法、超音波画像法、磁気共鳴画像法および光学画像法、またはコンピューター支援断層撮影画像法を含む、項目4に記載の方法。
6.前記エネルギー伝導性デバイスが、前記画像を見ているユーザーによって、リアルタイムで、手動で配置される、項目4に記載の方法。
7.前記エネルギー伝導性デバイスが、前記画像に応答してシステムを配置することによって、自動的に配置される、項目4に記載の方法。
8.前記組織が気化する場合に生成される蒸気を収集する工程、および前記組織表面にわたって該蒸気を除去する工程をさらに包含する、項目1または2に記載の方法。
9.前記蒸気を収集および除去する工程が、該蒸気を前記除去容量から吸引する工程を包含する、項目8に記載の方法。
10.前記組織が気化された場合に生成する蒸気を、前記シャフトの管腔を通して吸引する工程をさらに包含する、項目2に記載の方法。
11.前記シャフトを移動する工程が、該シャフトをその軸の周りで回転させる工程を包含する、項目2に記載の方法。
12.前記シャフトを移動する工程が、該シャフトを軸方向で往復移動する工程を包含する、項目2に記載の方法。
13.前記要素を再配置する工程が、該要素を、前記シャフト上の回転点の周りで回転させる工程を包含する、項目2に記載の方法。
14.前記要素を再配置する工程が、該要素を直線状構成と弓状構成との間で湾曲させる工程を包含する、項目2に記載の方法。
15.前記要素にエネルギー供給する工程が、高周波数の電流を送達する工程を包含する、項目1または2に記載の方法。
16.前記高周波数のエネルギーが、双極様式で、前記要素と前記標的部位にかまたはその付近に配置された電極との間に送達される、項目15に記載の方法。
17.前記高周波数のエネルギーが、単極様式で、前記要素と患者の外皮上の皮膚パッドとの間に送達される、項目15に記載の方法。
18.前記高周波数のエネルギーが、切断波形、100kHz〜2MHzの範囲の周波数、および1mA〜50Aの範囲の電流を有する、項目15に記載の方法。
19.凝固波形を有する無線周波数を、除去の後に残る組織に印加する工程をさらに包含する、項目18に記載の方法。
20.前記要素にエネルギー供給する工程が、該要素を加熱する工程を包含する、項目1または2に記載の方法。
21.前記要素が、100℃〜300℃の範囲の温度まで加熱される、項目19に記載の方法。
22.光学エネルギーを前記要素に向けることによって、該要素が加熱される、項目19に記載の方法。
23.前記要素が、電流で抵抗加熱される、項目19に記載の方法。
24.前記除去容量が、球状または卵型構造を有する、項目1または2に記載の方法。
25.前記除去容量が、円筒形構造を有する、項目1または2に記載の方法。
26.前記除去容量が、0.5cm3〜500cm3の範囲の容量を有する、項目1または2に記載の方法。
27.組織切除デバイスであって、該デバイスが、以下:
近位端、遠位端、およびそれらを通る管腔を有するシャフト;
該シャフトの該遠位端付近に配置された、少なくとも1つの可撓性エネルギー伝達要素;
該要素を実質的に直線状プロフィールと一連の弓状プロフィールとの間で湾曲するための手段であって、該直線状プロフィールにおいて、該要素は該シャフトの上に直接位置し、そして該一連の弓状プロフィールは該シャフトから次第に間隔をあけられている、手段;
該シャフトの該近位端付近の該管腔に連結された吸引コネクタ;および
該シャフトの該近位端付近に配置され、そして該エネルギー伝達要素に電気的に連結された、電源コネクタ、を備える、デバイス。
28.前記シャフトが実質的に剛性である、項目26に記載のデバイス。
29.前記シャフトが、0.1mm〜20mmの範囲の直径、および0.5cm〜50cmの範囲の長さを有する、項目27または28に記載のデバイス。
30.前記シャフトが可撓性であり、そして25cm〜250cmの範囲の長さを有する、項目27に記載のデバイス。
31.前記シャフトの前記近位端に固定されたハンドルをさらに備える、項目26に記載のデバイス。
32.前記吸引コネクタおよび/または前記電源コネクタが、前記ハンドルの上に配置される、項目29に記載のデバイス。
33.前記シャフトの前記近位端に取付け可能なモーターをさらに備える、項目26に記載のデバイス。
34.前記モーターが、前記シャフトを回転させ、かつ前記エネルギー伝達要素を該シャフトに対して移動するように取り付けられる、項目31に記載のデバイス。
35.前記エネルギー伝達要素が、高周波数の電気エネルギーを伝導する電極を備える、項目26に記載のデバイス。
36.前記エネルギー伝達要素が、加熱要素を備える、項目26に記載のデバイス。
37.前記加熱要素が、前記エネルギー伝達要素を加熱するために、光エネルギーを送達するための光ファイバを備える、項目34に記載のデバイス。
38.前記加熱要素が、電気抵抗ヒーターを備える、項目34に記載のデバイス。
39.前記エネルギー伝達要素が、ワイヤを備える、項目26に記載のデバイス。
40.前記要素が、リボンを備える、項目26に記載のデバイス。
41.少なくとも2つ以上のエネルギー伝達要素を備える、項目26に記載のデバイスであって、ここで、前記湾曲手段が、実質的に同じ速度で該要素を湾曲するように適合される、デバイス。
42.少なくとも1つのワイヤ電極および少なくとも1つのリボン電極を備える、項目26に記載のデバイスであって、ここで前記電気コネクタが、該ワイヤおよびリボン電極の、高周波数電源の反対の極への接続を提供する、デバイス。
43.前記湾曲手段が、前記ワイヤ電極を、前記リボン電極の前で半径方向に前進させる、項目40に記載のデバイス。
44.組織切断デバイスであって、該デバイスが、以下:
近位端、遠位端、およびそれらを通る管腔を有するシャフト;
該シャフトの遠位端付近に回転的に取り付けられた、実質的に剛性のエネルギー伝達要素;
該要素を該シャフトに対して回転させるための手段;
該シャフトの該近位端付近の該管腔に連結された、吸引コネクタ;および
該シャフトの該近位端付近に配置され、そして該エネルギー伝達要素に電気接続された、電源コネクタ、を備える、デバイス。
45.前記シャフトが実質的に剛性である、項目42に記載のデバイス。
46.前記シャフトが、0.1mm〜20mmの範囲の直径、および0.5cm〜50cmの範囲の長さを有する、項目42または43に記載のデバイス。
47.前記シャフトが、0.1mm〜20mmの範囲の直径、および0.5cm〜50cmの範囲の長さを有する、項目42に記載のデバイス。
48.前記シャフトの前記近位端に固定されたハンドルをさらに備える、項目42に記載のデバイス。
49.前記吸引コネクタおよび前記電源コネクタが、前記ハンドルの上に配置される、項目45に記載のデバイス。
50.前記シャフトの前記近位端に取り付けられたモーターをさらに備える、項目42に記載のデバイス。
51.前記モーターが、前記シャフトを回転させ、かつ前記エネルギー伝達要素を該シャフトに対して移動するように取り付けられる、項目47に記載のデバイス。
52.前記エネルギー伝達要素が、高周波数電気エネルギーを伝導する電極を備える、項目42に記載のデバイス。
53.前記エネルギー伝達要素が、加熱要素を備える、項目42に記載のデバイス。
54.前記加熱要素が、前記エネルギー伝達要素を加熱するために、光エネルギーを送達するための光ファイバを備える、項目50に記載のデバイス。
55.前記加熱要素が、電気抵抗ヒーターを備える、項目50に記載のデバイス。
56.前記実質的に剛性のエネルギー伝達要素が、15mm〜75mmの範囲の長さ、および1mm〜5mmの範囲の幅を有する、項目42に記載のデバイス。
57.前記実質的に剛性のエネルギー伝達要素が、円形または平坦な断面である、項目53に記載のデバイス。
58.前記実質的に剛性のエネルギー伝達要素が直線状のピンを備え、該ピンが、その中間付近で、前記シャフトに回転的に取り付けられる、項目42に記載のデバイス。
59.前記実質的に剛性のエネルギー伝達要素が直線状のピンを備え、該ピンが、その一端付近で、前記シャフトに回転的に取り付けられる、項目42に記載のデバイス。
60.キットであって、該キットが、以下:
電源に接続可能であるエネルギー伝達要素を有するデバイスであって、該電源は、該要素が組織の連続層を通って移動される場合、該組織の連続層を気化するのに十分なエネルギーを提供する、デバイス;および
項目1または2に記載の方法を記載する使用説明書、を備える、キット。
61.項目60に記載のキットであって、前記デバイスは滅菌パッケージ内に存在し、前記使用説明書は、該パッケージの一部に印刷されるか、または該パッケージに添付された別の説明書シート上にある、キット。
ここで図1を参照すると、組織切除デバイス10は、遠位端14および近位端16を有するシャフト12を備える。エネルギー伝達要素18(代表的には、強固な円柱状の電極またはピン)が、シャフト12の遠位端に点19にて取り付けられている。ハンドル20が、このシャフトの近位端16に接続されており、そして親ねじ22が、このハンドルに対して要素18の旋回および/またはシャフト12の回転を引き起こすように、このハンドルの遠位端付近に提供されている。通常、この親ねじ20は、このシャフト12を通りそしてその遠位端付近にあらわれる押し/引きワイヤ21を介して、この旋回する要素18に接続されている。この押し/引きワイヤ21が、要素18の外側末端付近に取り付けられていることが示されており、もちろんこの押し/引きワイヤ21は、ピボットピンにもっと大いに近くに接続され得る。さらに、他の多数の旋回機構が、上記のように、提供され得る。
Claims (16)
- 組織切除システムであって、該システムが以下:
組織切除デバイスであって、該デバイスが、以下:
近位端、遠位端、およびそれらを通る管腔を有するシャフトであって、該シャフトは、長軸を規定する、シャフト;
該シャフトの遠位端付近において該シャフト上の固定点に旋回的に取り付けられた直線状のピンである、実質的に剛性のエネルギー伝達要素であって、該伝達要素は、第一の遠位端および第二の遠位端を備え、ここで、該両方の遠位端は伝導性である、伝達要素;
該伝達要素の両方の遠位端を該シャフトに対して旋回させるための手段であって、該シャフトを通り、該伝達要素の該遠位端のうちの1つに取り付けられた押し/引きワイヤを含み、該両方の遠位端は、該シャフトの該長軸に直交する軸のまわりで旋回する、旋回させるための手段;
該シャフトの該近位端付近の該管腔に連結された、吸引コネクタ;および
該シャフトの該近位端付近に配置され、そして該エネルギー伝達要素に電気接続された、電源コネクタ、
を備える、デバイス;ならびに
該シャフトの遠位端から該管腔を通して、蒸気および/または材料が引き抜かれることを可能にする、該吸引コネクタに結合した真空供給源、
を備える、システム。 - 前記シャフトが実質的に剛性である、請求項1に記載のシステム。
- 前記シャフトが、0.1mm〜20mmの範囲の直径、および0.5cm〜50cmの範囲の長さを有する、請求項1または2に記載のシステム。
- 前記シャフトが、0.1mm〜20mmの範囲の直径、および0.5cm〜50cmの範囲の長さを有する、請求項1に記載のシステム。
- 前記シャフトの前記近位端に固定されたハンドルをさらに備える、請求項1に記載のシステム。
- 前記吸引コネクタおよび前記電源コネクタが、前記ハンドルの上に配置される、請求項5に記載のシステム。
- 前記シャフトの前記近位端に取り付けられたモーターをさらに備える、請求項1に記載のシステム。
- 前記モーターが、前記シャフトを回転させ、かつ前記エネルギー伝達要素を該シャフトに対して移動するように取り付けられる、請求項7に記載のシステム。
- 前記エネルギー伝達要素が、高周波数電気エネルギーを伝導する電極を備える、請求項1に記載のシステム。
- 前記エネルギー伝達要素が、加熱要素を備える、請求項1に記載のシステム。
- 前記加熱要素が、前記エネルギー伝達要素を加熱するために、光エネルギーを送達するための光ファイバを備える、請求項10に記載のシステム。
- 前記加熱要素が、電気抵抗ヒーターを備える、請求項10に記載のシステム。
- 前記実質的に剛性のエネルギー伝達要素が、15mm〜75mmの範囲の長さ、および1mm〜5mmの範囲の幅を有する、請求項1に記載のシステム。
- 前記実質的に剛性のエネルギー伝達要素が、円形の断面を有する、請求項1に記載のシステム。
- 前記実質的に剛性のエネルギー伝達要素が、(i)その中間付近で、前記シャフトに旋回的に取り付けられるか、または(ii)その一端付近で該シャフトに旋回的に取り付けられるかのうちの1つである、請求項1に記載のシステム。
- 前記実質的に剛性のエネルギー伝達要素は、前記シャフトに対して少なくとも90度またはそれ以上の範囲で旋回する、請求項1に記載のシステム。
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US6296639B1 (en) | 2001-10-02 |
JP2011172949A (ja) | 2011-09-08 |
JP2006095295A (ja) | 2006-04-13 |
EP1158921A4 (en) | 2003-02-05 |
US7192430B2 (en) | 2007-03-20 |
US6663626B2 (en) | 2003-12-16 |
ATE406848T1 (de) | 2008-09-15 |
EP1158921B1 (en) | 2008-09-03 |
US20040054368A1 (en) | 2004-03-18 |
US20070293853A1 (en) | 2007-12-20 |
JP2002536107A (ja) | 2002-10-29 |
WO2000047123A9 (en) | 2001-08-09 |
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